Artificial valve

ABSTRACT

The invention discloses an artificial valve ( 10, 20, 30, 50 ) for implantation in a mammal body, in or adjacent to a mammal blood vessel, comprising a casing ( 12, 37, 61 ) and a closing mechanism, with at least part of said closing mechanism being a first moving part ( 11; 21, 22; 31, 32, 33; 51 ) adapted to make movements relative to said casing ( 12, 37, 61 ), said movements being to assume an open and a closed position for opening and closing, respectively, the blood flow through said blood vessel, as well as to positions in between said open and closed positions. In the valve of the invention, the closing mechanism is adapted to be powered in its movements to the closed position, with the powering being at least in part by means of a power mechanism ( 76, 83 ) external to the blood vessel.

This application is the U.S. national phase of International ApplicationNo. PCT/SE2009/051148, filed 12 Oct. 2009, which designated the U.S. andclaims the benefit of Swedish Application No. 0802157-8, filed 10 Oct.2008 and U.S. Provisional Application No. 61/213,157, filed 12 May 2009,the entire contents of each of which are hereby incorporated byreference.

TECHNICAL FIELD

The present invention discloses an artificial valve for implantation ina mammal body, in or adjacent to a mammal blood vessel. The valve of theinvention comprises a casing and a closing mechanism, and at least partof the closing mechanism is a moving part adapted to make movementsrelative to the casing.

BACKGROUND

Artificial valves for implantation into mammal blood vessels are used inorder to replace existing valves in the circulatory system of a mammal.When implanted in the circulatory system of a mammal, such valves areused to regulate the flow of blood in the mammal by means of closing oropening the blood flow in the vessel, which is accomplished by lettingone or more moving parts in the valve assume a closed position or tomove to assume an open position.

SUMMARY

It is an object of the present invention to provide an artificial valvefor implantation into a mammal blood vessel which overcomes drawbacks ofknown such artificial valves.

This object of the present invention is achieved by means of anartificial valve for implantation in a mammal body, in or adjacent to amammal blood vessel. The artificial valve of the invention comprises acasing and a closing mechanism, and at least part of the closingmechanism is a first moving part which is adapted to make movementsrelative to the casing. The movements are movements to assume an openand a closed position for opening and closing, respectively, the bloodflow through said blood vessel, as well as to positions in between saidopen and closed positions. The first moving part is adapted to receiveenergy for at least one of its movements at least in part from an energydevice which is also comprised in the artificial valve and arranged tobe placed external to said blood vessel.

In one embodiment of the valve of the invention, the closing mechanismis arranged to cause the first moving part to move between two desiredpositions by means of giving the moving part kinetic energy in aplurality of steps in its movement between said two desired positions.

In one embodiment of the valve of the invention, the closing mechanismcomprises one or more magnets adapted to receive energy from the energydevice as a first pulse, said one or more magnets further being adaptedto receive one or more additional pulses with a time delay in relationto said first pulse to cause said kinetic movement of said first valvemember.

In one embodiment of the valve of the invention, the closing mechanismcomprises at least two magnets, said closing mechanism being adapted toreceive said additional pulses to affect a different magnet or adifferent group of magnets than said first pulse.

In one embodiment of the valve of the invention, the closing mechanismcomprises a coil which is adapted to be energized so as to cause saidmovement of the closing mechanism.

In one embodiment of the valve of the invention, the closing mechanismcomprises a coil which is adapted to be energized stepwise with two ormore energy pulses so as to cause said movement of the closingmechanism.

In one embodiment of the valve of the invention, the closing mechanismcomprises a plurality of coils which are adapted to be energizedstepwise so as to cause said movement of the closing mechanism.

In one embodiment of the valve of the invention, at least either themagnets or the coils are arranged at intervals in the casing along anintended path of movement of the moving part.

In one embodiment of the valve of the invention, the first moving partis adapted to move to assume an open or a closed position as well aspositions in between said open and closed positions. Suitably, in thisembodiment, the valve also comprises first and second hinges arranged inthe casing, about which hinges the first moving part is arranged to beable to move to assume an open or a closed position as well as positionsin between said open and closed positions.

In one embodiment, the closing mechanism of the valve also comprises asecond moving part, and the first and second moving parts are adapted tomove to assume a closed and an open position as well as to positions inbetween said open and closed positions, in order to close or limit theblood flow through the blood vessel. Suitably, in this embodiment, thefirst and second moving parts are movably hinged about respective firstand second hinges in the casing, and can move about these hinges toassume an open or a closed position as well as positions in between saidopen and closed positions.

In one embodiment, the closing mechanism of the valve also comprises asecond and a third moving part, and the first, second and third movingparts are adapted to move to assume a closed and an open position aswell as positions in between said open and closed positions in order toclose or limit the blood flow through the blood vessel. Suitably, inthis embodiment, the first, second and third moving parts are movablyhinged about respective first and second hinges in the casing, and canmove about these hinges in order to assume an open or a closed positionas well as positions in between said open and closed positions.

In one embodiment, the closing mechanism of the valve comprises anadditional three or more moving parts, and the moving parts of the valveare adapted to move to assume a closed and an open position as well aspositions in between said open and closed positions in order to close orlimit the blood flow through the blood vessel. Suitably, in thisembodiment, each of the moving parts is movably hinged about respectivefirst and second hinges in said casing, and can move about these hingesin order to assume an open or a closed position as well as positions inbetween said open and closed positions.

Suitably, in the embodiments with two or more moving parts, the movingparts come together to form a cupola in the closed position, and alsosuitably, the first and second hinges of at least one of said movingparts are positioned at or adjacent to a meeting point of the movingparts. In addition, in these embodiments, the first and second hinges ofat least one of said moving parts are placed at substantially oppositedistal ends of said moving part along the casing.

In another embodiment, the closing mechanism of the valve of theinvention comprises an elongated essentially flat plate which is adaptedto, when the valve is arranged in or adjacent to an opening in saidblood vessel, move into this opening in a direction which is essentiallyperpendicular to the blood vessel in order to limit or close the bloodflow through said vessel.

In one embodiment with the plate, an outer wall of the casing issuitably concavely curved in order to essentially coincide with theouter shape of a blood vessel, and the curved outer wall also comprisesan opening for the plate, through which opening the plate can move inits movements. The tolerance between the dimensions of the opening andthe plate are then such that the movements of the plate are enabled, butalso such that leakage of blood between the plate and the opening isessentially eliminated.

In the “plate embodiment”, the casing also suitably comprises at least afirst curved protruding part in order to surround at least part of thecircumference of a blood vessel, in order to enable attachment of thevalve to the blood vessel.

In another embodiment, the casing comprises at least a first and asecond curved protruding part for surrounding at least part of thecircumference of a blood vessel, in order to enable attachment of thevalve to the blood vessel.

The valve of the “plate embodiment” can also, in one embodiment,comprise a detachable part for attachment to the casing or to one ormore protruding parts of the casing, so that the valve will completelysurround a blood vessel by means of at least one protruding part andsaid detachable part and/or by means of an outer wall of the valve.

In the plate embodiments, the valve of the invention can also comprise abiasing mechanism, for biasing the plate to an open position.

The valve of the invention also suitably comprises a receiving devicefor receiving a closing signal, and for supplying this closing signal tothe closing mechanism, which in turn is adapted to close upon receptionof said signal.

The closing signal may be received by the receiving device from a sourceexternal to the valve, or it may be received from a sensor which iscomprised in the valve. In both of these embodiments, the signal issupplied as the result of a parameter reaching a certain threshold valueat which the valve should initiate its closing movement.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be described in more detail in the following, withreference to the appended drawings, in which

FIGS. 1a and 1b show side views of a first embodiment of the inventionin an open and a closed position.

FIGS. 2a-2d show side views of a second and a third embodiment in openand a closed position.

FIGS. 3a-3e show views of a fourth embodiment in various positions.

FIGS. 4a and 4b show a valve of the invention implanted in a bloodvessel.

FIGS. 5a and 5b show a further embodiment of the invention together witha blood vessel.

FIGS. 6-10 show views of the embodiment of FIGS. 5a and 5 b.

FIGS. 11-15 show various versions of the invention.

FIGS. 16-18 show versions of powered movements.

FIG. 19 illustrates a system for treating a disease, wherein the systemincludes an apparatus of the invention implanted in a patient.

FIGS. 20-34 schematically show various embodiments of the system forwirelessly powering the apparatus shown in FIG. 19.

FIG. 35 is a schematic block diagram illustrating an arrangement forsupplying an accurate amount of energy used for the operation of theapparatus shown in FIG. 19.

FIG. 36 schematically shows an embodiment of the system, in which theapparatus is operated with wire bound energy.

FIG. 37 is a more detailed block diagram of an arrangement forcontrolling the transmission of wireless energy used for the operationof the apparatus shown in FIG. 19.

FIG. 38 is a circuit for the arrangement shown in FIG. 20, according toa possible implementation example.

FIGS. 39-45 show various ways of arranging hydraulic or pneumaticpowering of an apparatus implanted in a patient.

FIG. 46 shows a system of the invention.

FIGS. 47 and 48 show an embodiment of the invention.

FIGS. 49-52 illustrate an operation method of the invention.

DETAILED DESCRIPTION

The invention will be described in the following with reference to ahuman blood vessel, and may also be described below as being placed in ahuman heart. It should however be pointed out that these are merelyexamples given in order to facilitate the reader's understanding of theinvention; the artificial valve of the invention can be used at more orless any point in the circulatory system of any mammal.

In addition, the artificial valve of the invention can be used in orderto replace a biological valve, as an alternative to which it can be usedin order to supplement a biological valve, or to create a “valvefunction” in a position where the body is normally not equipped with avalve function.

As has been mentioned above, the present invention discloses anartificial valve for implantation in a mammal body, in or adjacent to amammal blood vessel. The valve of the invention comprises a casing and aclosing mechanism, and at least part of the closing mechanism is amoving part which is adapted to make movements relative to the casing.These movements enable the moving part of the closing mechanism toassume an open and a closed position for opening and closing,respectively, the blood flow through the blood vessel, as well as topositions in between said open and closed positions.

The closing mechanism of the valve is adapted to be powered in itsmovements to the closed position in part or entirely by means of a powermechanism external to said blood vessel.

Before the powering of the closing mechanism is described in moredetail, some embodiments of the closing mechanism as such will first bedescribed. FIG. 1a shows a side view of a first embodiment 10 of anartificial valve of the invention. As seen in FIG. 1a , in thisembodiment, the closing mechanism of the valve comprises a first movingpart 11, suitably essentially shaped as a disc in order to enable theclosing of a blood vessel. The valve 10 also comprises a casing 12 inwhich the moving part 11 is housed.

As is also shown in FIG. 1a , the casing 12 comprises a ring, which isshaped so that the disc 11 may rotate in the casing to assume open andclosed positions, as well as positions in between said open and closedpositions. In order to enable the rotation of the disc 11, the valve 10also comprises first 13 and second 13′ hinges arranged in the casing,about which hinges the disc can rotate. As will be realized, in the openposition, shown in FIG. 1b , the disc 11 is essentially perpendicular tothe casing 12, while it in the closed position is essentially alignedwith an inner wall of the casing 12.

FIG. 1b shows a side view of the embodiment 10 in the open position.

In a second embodiment 20, shown in a side view in FIG. 2a , the closingmechanism of the valve comprises a first 21 and a second 22 moving part,each of which moving part is movably hinged about respective first 23,23′ and second 24, 24′, hinges in a ring-shaped casing 12.

The first 21 and second 22 parts can move about their respective hingesto assume a closed and an open position, as well as positions in betweensaid open and closed positions in order to close or limit the blood flowthrough said blood vessel.

FIG. 2b shows the valve 20 in a side view. As can be seen here, the twoparts 21 and 22 are essentially flat halves of a flat disc, while FIGS.2c and 2d show an embodiment 20′ in which the two moving parts 21, 22,come together to form a cupola in the closed position of the valve 20.FIGS. 2c and 2d also show parts 38 of a closing mechanism which will bedescribed in more detail later in this text.

In a further embodiment 30 of the inventive valve, which is shown in aplan view in FIG. 3a , the closing mechanism of the valve comprisesfirst 31, second 32 and third 33 moving parts, each of which is movablyhinged about respective first 34, 35, 36 and second 34′, 35′, 36′,hinges in a ring-shaped casing 37.

In this embodiment, the first 31, second 32 and third 33 moving partscan move about their respective hinges to assume a closed and an openposition as well as positions in between said open and closed positionsin order to close or limit the blood flow through said blood vessel,

The words “open” and “closed” positions for the embodiments 20 and 30 ofthe valve should here be taken to mean that each moving part can assumea closed and an open position, but that each part needs to be in itsclosed position in order for the blood flow through a blood vessel to beclosed, and that a maximally open valve is achieved when each movingpart is in its open position.

As shown in side views in FIGS. 3b and 3c , in similarity to theembodiment 20 shown in FIGS. 2c and 2d , in the “three part embodiment”30, the moving parts suitably come together to form a cupola in theclosed position.

FIG. 3d shows the embodiment 30 in the open position, and FIG. 3e showsone of the cupola parts 31 with its hinges 34, 34′.

As shown in the views of FIGS. 2a and 3a , in the embodiments 20 and 30,the first and second hinges of at least one of the moving parts of thevalve of those embodiments are positioned at or adjacent to a meetingpoint of the moving parts.

Also suitably, which can also be seen in the views of FIGS. 2a and 3a ,the first and second hinges of at least one of the moving parts of thevalve of those embodiments are placed at substantially opposite distalends of the moving part along the casing.

This positioning of the hinges allows for a smoother and easier movementof the moving parts of the valve, as opposed to the hinges oftraditional valves, which are usually placed at a centre position of themoving part.

As has emerged from the description above, the valve of the inventionfeatures “powered closing”, i.e. powered movement of the closing parts,but as an alternative, the closing mechanism of the valve in theembodiments 20 and 30 is also adapted to be at least partly closed bythe flow of blood, so that the flow of blood will bring the closingmechanism with it in a closing movement. In other words, the flow ofblood in the “back direction” can in such embodiments assist the poweredmechanism of the valve in closing the valve. This can also be seen asletting the closing mechanism be adapted to be at least partly closed byblood pressure of a certain level.

FIGS. 4a and 4b show the valve 30 in a blood vessel 52, in the open(FIG. 4a ) and closed (FIG. 4b ) positions. It can be gleaned from thesedrawings (as also indicated by means of an arrow in the blood vessel 52)that in some embodiments, the flow of blood will be used to assist inthe closing movement of the moving parts, as well as possibly (FIG. 4a )also in the opening movement of the moving parts.

Some different way of how the closing mechanism of the embodiments canbe powered in its movements will now be described, before a differentversion of the valve of the invention is described.

The powering of the movements of the closing mechanism is shown in FIGS.16-18 below, and is based on the casing having a first H and second H′casing part, with the first part being displaceable in relation to thesecond part in order to cause the opening and/or closing movement.Suitably, the first H and second H′ casing parts each comprise a ring,with the two rings being concentric to each other, and with one of thefirst or second rings being adapted to move in relation to the otherpart in order to cause the closing and/or opening movement.

As can be seen in FIGS. 16a and 16b , the two parts H′ and H of thecasing each constitute rings and can be made to move away from eachother or towards each other, i.e. essentially in the direction of the“axis” of a blood vessel. Suitably, only one of the casing parts shouldbe made to move.

In the embodiment of FIGS. 16a and 16b , the ring H, which is the mostdistant from the moving parts of the cupola, has one end of each ofthree mechanical elements K, for example three pins, attached to it,with the other ends of the pins being attached to one each of the movingparts of the cupola.

As the distance between the two parts of the casing, H and H′, is madeto increase or decrease, by means of, for example, magnets and coils,the pins will cause the cupola parts to move about their hinges andopen, FIG. 16b , or close, FIG. 16 a.

FIGS. 17a-17d show another embodiment in which the casing parts are alsoconcentric rings H′, H. However, in this embodiment, the opening and/orclosing movement of the cupola parts is obtained by letting the ringsrotate in relation to each other, suitably with only one of the ringsrotating.

As can be seen in FIGS. 17a-17d , the ring H which can be made torotate, for example by means of interaction between springs on one ringand coils on the other, comprises three pins, J, which can move incorresponding openings I of the other ring H′.

As can also be seen in FIGS. 17a-17d , the cupola parts comprise agroove N (not a through-going groove though) in which the pin J can run.The groove N is slanted in the cupola part, so that rotation of the ringH with the pins J will cause the cupola parts to open or close,depending on the direction of rotation of the ring H.

FIG. 18 shows another embodiment of how the cupola parts may be made toopen and/or close actively as well as passively; in this embodiment aswell, the casing comprises an upper N and a lower O ring shaped part,which are essentially concentric.

One of the ring shaped parts, O, comprises a groove P, which consists ofvertical and slanted parts, in an alternating fashion. A pin M from eachcupola part runs in this groove P. If the blood pressure increases, thecupola part will open, since the pin will move in a vertical (i.e.essentially parallel with the extension of a blood vessel) part of thegroove, and can also be closed when the blood begins to flow in thereverse direction, i.e. during the diastolic phase of the heart.

However, if the ring O with the groove P in it is made to rotate, thepin will be forced to move in or by a slanted part of the groove, whichwill also cause the cupola part to perform a closing or openingmovement, depending on the direction of rotation of the ring. Amechanism for making the ring O rotate is indicated as Q in FIG. 18.

FIG. 47 shows a further embodiment for powering the “cupolaembodiments”: a cupola embodiment with three parts, 31, 32, and 33 isshown as an example of such an embodiment. On each cupola part, there isarranged a “ladder” of magnets 804-806 (shown only on cupola part 33),i.e. magnets arranged in line essentially in the direction of movementof the cupola part.

On a ring O′ which is part of the casing of the valve 30, there isarranged a coil 801, 802, 803, which is positioned so that energizing(by means of AC current/voltage) the coil will affect one or more of themagnets on the corresponding cupola part, and will thus cause the cupolapart to perform an opening or closing movement. Naturally, the coil canbe energized to affect to the magnets step-wise, i.e. one at a time ascupola part moves past the coil.

An alternative embodiment of the invention, shown in FIGS. 5a-10d ,comprises one or more of the following features, singly or incombination:

-   -   The first moving part of the closing mechanism is adapted to        assume a position at least partly placed outside of the blood        vessel when the valve is in a non-closed position in the mammal        body.    -   The first moving part is adapted to, when the valve is arranged        in or adjacent to an opening in said blood vessel 52, move in an        opening in the blood vessel to limit or close the blood flow        through said vessel, with at least a portion of said first        moving part 51 assuming a position external to said blood vessel        in a non-closed position.    -   The first moving part is arranged to move in said opening in a        direction which is essentially perpendicular to the extension of        the blood vessel.    -   The first moving part comprises an elongated essentially flat        plate 51 which is adapted to, when the valve is arranged in or        adjacent to an opening in said blood vessel 52, move in a        direction essentially perpendicular to said blood vessel to        limit or close the blood flow through said vessel, with at least        a portion of said first moving part 51 assuming a position        external to said blood vessel in a non-closed position.    -   The closing mechanism is housed in the casing 61, with the first        moving part 51 being adapted to protrude from the housing 61 in        its closing movements.    -   The valve 50 also comprises a biasing mechanism 82 for biasing        the plate 51 to an open position.    -   The biasing mechanism comprises a spring mechanism 82.    -   The first moving part 51 is given a curved or semicircular shape        at the end 53 of the part which will be the first to enter said        opening in the blood vessel during a closing movement of the        first moving part 51, whereby the first moving part is adapted        to fit against a distal inner wall of the blood vessel in order        to close or limit the passage of blood in said blood vessel.    -   An outer wall 62 of the casing 61 is concavely curved to        essentially coincide with the outer shape of a blood vessel,        said curved outer wall 62 also comprising an opening 63 for the        first moving part 51, through which opening it can move in its        movements, with the tolerance between the dimensions of the        opening and the first moving part being such that the movements        are enabled, but also such that leakage of blood between the        first moving part and the opening is essentially eliminated.    -   The casing 61 also comprises at least a first curved protruding        part 64, 65 for surrounding at least part of the circumference        of a blood vessel 52, for attachment of the valve to said blood        vessel.    -   The casing 61 also comprises at least first 64 and second 65        curved protruding parts for surrounding at least part of the        circumference of a blood vessel, for attachment of the valve to        said blood vessel.    -   The protruding part or parts, together with said concave outer        wall, are adapted to be attached to the blood vessel by means of        a vascular graft 82.    -   The valve 50 also comprises a detachable part 71 for attachment        to one or more protruding part 64, 65 or to the casing 61, so        that the valve may completely surround a blood vessel by means        of at least one protruding part and said detachable part and/or        by means of an outer wall of the valve.    -   The valve 50 also comprises a protruding guide 81 for guiding        the movements of the plate 51 in the blood vessel, said guide 81        thus being intended for arrangement inside the blood vessel and        being essentially shaped to coincide with the outer form of the        plate 51, with a certain tolerance to enable the plate 51 to        move in the guide.

This embodiment 50 is shown in one aspect in a plan view in FIG. 5a ,together with a blood vessel 52; the closing mechanism of the valvecomprises an elongated and essentially flat plate 51 which is adaptedto, when the valve 50 is arranged in or adjacent to an opening in theblood vessel 52, move into this opening in a direction which isessentially perpendicular to the blood vessel in order to limit or closethe blood flow through said vessel. The direction of movement of theplate 51 is indicated by means of an arrow “A” in FIG. 5 a.

As can be seen in FIG. 5a , in one embodiment, the flat plate 51 isgiven a curved or semicircular shape at the end 53 of the plate 51 whichwill be the first to enter an opening in the blood vessel 52 during aclosing movement, and by means of the curved shape of the end 53, theplate 51 is then adapted to fit against a distal inner wall of the bloodvessel 52 in order to close or limit the passage of blood in said bloodvessel.

The blood vessel 52 is shown in a perspective view in FIG. 5b , togetherwith an opening 54 which is made in the blood vessel in order to admitthe plate 51.

The flat plate 51 is arranged in or adjacent to a casing 61, which isshown in a perspective view in FIG. 6. As can be seen in FIG. 6, in oneembodiment, an outer wall 62 of the casing 61 is concavely curved sothat it will essentially coincide with the outer shape of a blood vesselagainst which the casing 61 will be arranged. The curved outer wall 62also comprises an opening 63 for the plate 51, through which opening theplate can move in its movements, In this embodiment, the tolerancebetween the dimensions of the opening and the plate should be such thatthe movements of the plate 51 are enabled, but also such that leakage ofblood between the plate 51 and the opening 63 is essentially eliminated.

In one embodiment, also shown in FIG. 6, in order to make it possible toattach the valve 50 securely to a blood vessel, the casing 61 alsocomprises at least a first curved protruding part 64 for surrounding atleast part of the circumference of a blood vessel. In anotherembodiment, the casing 61 also comprises a second curved protruding part65 for surrounding at least part of the circumference of a blood vessel,so that the two parts 64, 65 may be arranged on opposite sides of ablood vessel to which the valve 50 is to be attached.

In some patients or in some positions in a patient's body, it may bepossible to attach the valve 50 to a blood vessel 52 by means of lettingthe casing 61 of the valve surround the blood vessel entirely, which isshown in FIG. 7. For such applications, the valve can be made to alsocomprise a detachable part 71 for attachment to the casing 61 or to oneor more of the protruding parts 64, 65. The valve may then be made tocompletely surround a blood vessel by means of at least one protrudingpart and said detachable part and/or by means of a curved outer wall ofthe valve, as shown in FIG. 7.

In the embodiments with the flat plate 51, the plate will thus in itsclosing movements move into (and out from, in an opening movement) aposition in a blood vessel. In one embodiment, show in a side view inFIGS. 8a and 8b , in order to guide the plate 51 in these movements, thecasing 61 of the valve also comprises a protruding guide 81 for guidingthe movements of the plate 51 in the blood vessel 52.

The guide 81 is thus intended for being arranged inside the blood vessel81, and is for that reason essentially shaped to coincide with the outerform of the plate, with a certain tolerance to enable the plate to movein the guide.

The guide 81 can be seen as an outer rail for the plate 51, and cancomprise grooves for the plate 51 to move in.

FIG. 8a also shows a vascular graft 82, by means of which the valve maybe attached to the blood vessel 52.

FIG. 9 shows a cross sectional view of a blood vessel 52, adjacent towhich a valve 50 of the “flat plate” embodiment has been arranged, withprotruding parts 64, 65, to which the detachable part 71 has beenattached, so that the casing entirely surrounds the blood vessel 52. Theflat plate 51 is also shown in FIG. 9, with its direction of movementbeing indicated by the arrow “A”. As will be realized particularly wellfrom FIG. 9, at least a portion of the moving part 51, i.e. a portion ofthe “flat plate”, will in a non-closed position assume a positionexternal to the blood vessel 52.

In some embodiments, the valve 50 will also preferably comprising abiasing mechanism for biasing the plate to an open position, so that thepowered movement has to overcome a biasing force in order to perform theclosing movement of the plate 51. Suitably, such a biasing mechanismcomprises a spring mechanism. This is shown in FIG. 10, which shows anopen side view of the valve 50 arranged adjacent to a blood vessel 52,and shows a possible spring mechanism 82 arranged in the casing 61.

As can be seen in FIG. 10a , the spring mechanism cooperates with anabutment on the plate 51, in order to bias the plate 51 to an openposition in the casing 61.

A suitable thickness for the plate 51 is 1 mm, although otherthicknesses are also well within the scope of the present invention.

FIGS. 10b-10d show how the movements of the moving part 51 may bepowered according to the invention, i.e. from an energy device externalto the blood vessel. As shown, the casing 61, or to be more exact, thepart or parts of the casing 61 which is arranged to house the movingpart 51 outside of the blood vessel 52 is equipped with one or morecoils 611-619, 611′-619′, which are arranged to be energized byalternating current, AC, so as to interact with one or more magnets620-622 magnets arranged on the moving part 51. The coils will thus intheir interaction with the magnets cause the movement of the moving part51.

The arrangement for running AC through the coils is not shown in thedrawings nor described here, since such an arrangement lies within thescope of what a man skilled in the field has knowledge of.

As mentioned, the following embodiment can, in a non-exclusive manner,be envisioned for a closing mechanism which comprises one or moreinteracting magnets and coils:

-   -   the closing mechanism comprises at least two magnets, said        closing mechanism being adapted to receive said additional        pulses to affect a different magnet or a different group of        magnets than said first pulse.    -   the closing mechanism comprises a coil which is adapted to be        energized so as to cause said movement of the closing mechanism.    -   the closing mechanism comprises a coil which is adapted to be        energized stepwise with two or more energy pulses so as to cause        said movement of the closing mechanism.    -   the closing mechanism comprises a plurality of coils which are        adapted to be energized stepwise so as to cause said movement of        the closing mechanism.

Regarding the “cupola embodiments” of the invention, their closingmechanism has been exemplified above in a number of ways, one of whichis cooperating coils and magnets in various numbers and combinations.Those embodiments of the closing mechanism for the cupola embodimentswhich comprise one or more cooperating coils and magnets can also bearranged to be powered from an energy device which is arrangedexternally to the blood vessel, as exemplified by an embodiment shown inFIG. 48: A first part of the closing mechanism, in the example shown inFIG. 48 a ring O′, is placed externally to the blood vessel 52. The coilor coils as described in the previous embodiments, here numbered 802,803, is/are arranged on the ring O′.

The cupola embodiment, with the cupola parts 31, 32, 33 hinged about aninner casing part O″, suitably also a ring, is then placed inside theblood vessel 52. The function of the interacting one or more coils andone or more magnets as described in the previous embodiments can then beperformed in the manner described above, but now with an energy devicein the form of the casing part O′ with the coils arranged externally tothe blood vessel 52.

Turning now to how and when the closing movements of the valve of theinvention will take place, this will be described in the following, andwill be shown using the drawings of the cupola embodiment 30 as anexample. It should however be pointed out that the same principle may beused in other embodiments of the invention, such as for example, the“flat plate” embodiment 50.

As shown in FIGS. 3a and 3c , the valve may be made to also comprise areceiving device, shown as 38 in FIGS. 3a and 3c . Although thereceiving device is shown in three parts in FIGS. 3a and 3c , thereceiving device can naturally also comprise one or two parts, or morethan three parts.

The receiving device or devices serve to receive a closing signal andfor supplying this closing signal to the closing mechanism, which inturn is adapted to close upon the reception of the closing signal. Theclosing mechanism and the receiving device can be integrated into oneunit, as shown throughout in the drawings, or they may be two separateunits in the valve.

The exact design of the receiving device 38 can vary, but in a preferredembodiment, the receiving device is adapted to receive the openingand/or closing signal as an electrical signal. This is shown in FIGS.11a and 11b , which also show, see FIG. 11a , that the signal may bereceived via cabling which is connected to the receiving device, or,FIG. 11b , that the signal may be received wirelessly, i.e. as radiosignals, so that the receiving device or devices comprise a wirelessreceiver. In the case of a wireless signal, the receiving device willalso in some embodiments comprise a demodulator for demodulating areceived wireless signal.

Turning now to more details of how the moving parts of the closingmechanism of the various embodiments are made to perform their closingmovements, this can be achieved in a large number of ways within thescope of the present invention, as will be obvious to those skilled inthe field.

However, as shown in FIG. 12, in one embodiment, the closing mechanismmay comprise one or more magnets, each of which interacts with a coil 83in order to create movement of the moving parts 31, 32, and 33. Asindicated in FIG. 12, each of the coils is arranged on the casing 37 ata central position for each moving part 31, 32, 33, with each of theinteracting magnets being arranged at a position on a moving part whichis immediately adjacent to the position of a coil. In the plateembodiment 50, the magnet is instead preferably placed on the plate, andthe coil is housed inside the casing. The coil 83 is also shown in theplate embodiment in FIG. 10.

In the “spring and coil” embodiment of the closing mechanism, the motionof the moving parts is caused by passing an AC current through thecoils.

In another embodiment, the closing mechanism comprises a mechanicalelement which is involved in the closing movements. A suitable exampleof such a mechanical element is a rotatable shaft, which may, forexample, in the case of the “cupola embodiment” 20, 30, be arranged tointeract with the hinges of the moving parts to cause the moving partsto open and/or to close.

In the “plate embodiment” 50, the rotatable shaft will instead bearranged inside the housing, and, for example, interacts with the plateby means of cogs.

Suitably, if a shaft is used, the rotatable shaft is attached to anengine which rotates the shaft, with the rotation of the shaft beingcontrolled by the signals received by the receiving device.

An example of the shaft embodiment is shown in FIG. 13, in which asymbolic shaft 76 is shown next to each of the hinge positions of themoving parts of the cupola. The engine which drives the shafts is notshown in FIG. 13.

Turning now to the signals which the receiving device of the valve isadapted to receive, these signals will in some embodiments be receivedfrom a source such as a sensor or some other device which is external tothe valve, with said source however being connected to the receivingdevice, for example by means of cabling or wirelessly, as describedabove. Such a sensor is shown in FIGS. 11a and 11b with the referencenumber 88.

The signals which the receiving device is adapted to receive from thisexternal source may be based upon a variety of parameters, some examplesof which will be given below. It should be understood that these signalsmay also be combined, so that the receiving device receives input frommore than one source or from more than one measurement:

In one embodiment, the receiving device of the valve is adapted toreceive input signals which are the result of the blood pressure orblood flow at a defined point in the circulatory system of the user ofthe valve reaching a predetermined threshold, which thus indicates thata closing movement should be carried out by the valve.

In one embodiment, the receiving device of the valve is adapted toreceive inputs signals as the result of a parameter which is related tothe contraction of a muscle at a defined point in the user of the valvereaching a predetermined threshold. For example, this may be ameasurement of the heart's phases, so that the valve is made to close atpredefined points of the systolic and/or diastolic phases of the heart.

In general, with regard to the valve operating in conjunction with theheart in a predefined manner, the input signals to the receiving devicemay be received as the result of one or more predefined body generatedparameters which is/are related to the contraction of the heart musclereaching a predetermined threshold. Examples of such parameters arethose mentioned, such as blood pressure, heart contractions (for examplemovement or bending or volume) and heart anti-contractions, and alsoheart electrical body generated signals.

In one embodiment, the artificial valve of the invention is adapted tocooperate with another device used by the mammal in question. Thus, insuch an embodiment, the receiving device is adapted to receive the inputsignals as the result of a device generated signal, suitably related tothe contraction of the heart. An example of such a device may be a socalled pacemaker, and in this case, the input signals would be signalswhich indicate that the mammal's heart has reached a certain phase atwhich the artificial valve should close. The pacemaker will then servethe role of the device 8 of FIGS. 11a and 11 b.

Thus, the receiving device can be adapted to receive said signal as theresult of a certain threshold value being reached by a physicalparameter of the mammal or a functional parameter of a device,

As described above, the valve may be designed to cooperate with anexternal device such as a sensor or a device used by the user, such as apacemaker. However, in alternative embodiments, as a complement orreplacement to external sensors and devices, the valve will in itselfcomprise a sensor for sensing one or more parameters, such as a physicalparameter of the mammal or a functional parameter of another device,such as, for example, the parameters enumerated above; such a sensorwill then also generate input signals to the receiving device of thevalve. This embodiment is shown in FIG. 14, in which the sensor 79 isshown as being arranged on the casing of the valve.

In one embodiment, the valve in addition comprises a control device forcontrolling the opening and closing of the valve, i.e. the movement ofthe moving parts of the valve. In this embodiment, the control devicereceives the input signals instead of or via the receiving device,processes the signals, and controls the operation of the valveaccordingly.

As indicated in FIG. 15, such a control device 87 suitably comprises aprocessor of some kind, for example a microprocessor, as well as amemory for storing executable code, and possibly also for storingparameters which are relevant to the operation of the valve, e.g.threshold parameters such as those mentioned above, and others.

Suitably, the control device controls the operating mechanism usinginput parameters which are received via the receiving device and/orsensed by an internal sensor.

As mentioned previously, the operating mechanism of the valve will inone embodiment comprise at least one magnet and at least one coil whichinteract with each other in order to cause an opening and/or closingmovement of at least one of the moving parts of the valve.

In an alternative embodiment, as a complement or alternative to thespring/coil mechanism, the operating mechanism is attached to thecasing, in the “cupola embodiments”, or housed in the casing, in thecase of the “plate embodiment”, and comprises at least two parts, with afirst part being adapted to move in relation to a second part to causean opening or closing movement of said moving parts. In one embodiment,the first part is then the rotating shaft mentioned previously, which inthe case of the “cupola embodiments” is adapted to rotateperpendicularly along the periphery of the blood vessel in which thevalve may be implanted.

Regarding the choice of material for the parts of the valve, the movingparts are suitably made of titanium, but any suitable material could beused; the casing may preferably be manufactured in a ceramic material,but for example stainless steel or plastic materials can also be used.The hinges may be manufactured in titanium, stainless steel, plasticmaterial or ceramics or any combination thereof.

In one embodiment, the moving parts of the valve are at least partiallygiven a structured surface, i.e. a surface which has a pattern or atexture on it, since this has been found to facilitate the growth ofmammal material upon a surface.

In one embodiment, the moving parts of the valve are at least partiallycovered by mammal valve material, such as that taken from a cow, a pigor a human being.

As shown in the drawings, the moving parts of the cupola, which can betwo or more, are all essentially equally shaped, so that they representessentially equal parts of the cupola. This is one embodiment, butembodiments in which the cupola is formed by unequally shaped parts arealso within the scope of the present invention, as well as embodimentswhich use more than three moving parts to form a cupola.

The invention also discloses methods for implanting a valve of theinvention into a mammal patient.

According to one embodiment of such a method, the following steps arecarried out:

-   -   inserting a needle or a tube-like instrument into the patient's        thoraxial or abdominal or pelvic cavity,    -   using the needle or tube-like instrument to fill a part of the        patient's body with gas, thereby expanding said cavity,    -   placing at least two laparoscopic trocars in said cavity,    -   inserting a camera through one of the laparoscopic trocars into        said cavity,    -   inserting at least one dissecting tool through one of said at        least two laparoscopic trocars,    -   dissecting an area of a potential place for a valve of said        blood vessel,    -   placing a device of the invention in said blood vessel, and    -   suturing in steps.

According to another embodiment of a method of the invention, thefollowing steps are performed:

-   -   cutting the skin of the mammal patient,    -   dissecting an area of a blood vessel,    -   placing said device in said blood vessel, and    -   suturing in steps.

According to another embodiment of a method of the invention, thefollowing steps are performed:

-   -   inserting a needle or a tube-like instrument into the patient's        thoraxial cavity,    -   using the needle or tube-like instrument to fill a part of the        patient's body with gas, thereby expanding said thoraxial        cavity,    -   placing at least two laparoscopic trocars in said cavity,    -   inserting a camera through one of the laparoscopic trocars into        said cavity,    -   inserting at least one dissecting tool through one of said at        least two laparoscopic trocars,    -   dissecting an area of a heart valve,    -   placing a device of the invention in said heart or connecting        blood vessel, and    -   suturing in steps.

According to another embodiment of a method of the invention, thefollowing steps are performed:

-   -   cutting the skin in the thoraxial wall of said mammal patient,    -   dissecting an area of the artificial heart valve,    -   placing the device of the invention in the heart or in a        connecting blood vessel, and    -   suturing in steps.

The method of the two embodiments described immediately above may alsoin one version include the following steps:

-   -   dissecting a path for a cable into the right atrium of the heart    -   cutting the skin and dissecting a subcutaneous place for a        control unit, similar to a pacemaker position    -   introducing the cable backwards from the right atrium of the        heart to the position of the control unit following the venous        blood vessels.

In this embodiment, the cable may also be made to reach vein subclaviaor vein cephalica and to exit from that vessel.

The method of the invention may suitably include the step of placing acontrol unit in the subcutaneous area and connecting it to a cable forsupplying the closing and/or opening signal to the valve.

In addition the method of the invention may comprise providing a powersupply to wirelessly supply energy to the valve, in which case thedissection and placing includes the following steps:

-   -   dissecting the area outside the heart valve    -   placing a wireless control unit including said power supply to        wirelessly supply the closing signal to said heart valve

The invention also discloses a system for powering and controlling anartificial device or apparatus such as that disclosed by the invention.

In a preferred embodiment, the system comprises at least one switchimplantable in the patient for manually and non-invasively controllingthe apparatus

In another preferred embodiment, the system comprises a wireless remotecontrol for non-invasively controlling the apparatus.

In a preferred embodiment, the system comprises a hydraulic operationdevice for operating the apparatus.

In one embodiment, the system comprises comprising a motor or a pump foroperating the apparatus.

FIG. 19 illustrates a system for treating a disease comprising anapparatus 10 of the present invention placed in the abdomen of apatient. An implanted energy-transforming device 302 is adapted tosupply energy consuming components of the apparatus with energy via apower supply line 303. An external energy-transmission device 304 fornon-invasively energizing the apparatus 10 transmits energy by at leastone wireless energy signal. The implanted energy-transforming device 302transforms energy from the wireless energy signal into electric energywhich is supplied via the power supply line 303.

The wireless energy signal may include a wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. Alternatively, the wireless energy signal may includean electric or magnetic field, or a combined electric and magneticfield.

The wireless energy-transmission device 304 may transmit a carriersignal for carrying the wireless energy signal. Such a carrier signalmay include digital, analogue or a combination of digital and analoguesignals. In this case, the wireless energy signal includes an analogueor a digital signal, or a combination of an analogue and digital signal.

Generally speaking, the energy-transforming device 302 is provided fortransforming wireless energy of a first form transmitted by theenergy-transmission device 304 into energy of a second form, whichtypically is different from the energy of the first form. The implantedapparatus 10 is operable in response to the energy of the second form.The energy-transforming device 302 may directly power the apparatus withthe second form energy, as the energy-transforming device 302 transformsthe first form energy transmitted by the energy-transmission device 304into the second form energy. The system may further include animplantable accumulator, wherein the second form energy is used at leastpartly to charge the accumulator.

Alternatively, the wireless energy transmitted by theenergy-transmission device 304 may be used to directly power theapparatus, as the wireless energy is being transmitted by theenergy-transmission device 304. Where the system comprises an operationdevice for operating the apparatus, as will be described below, thewireless energy transmitted by the energy-transmission device 304 may beused to directly power the operation device to create kinetic energy forthe operation of the apparatus.

The wireless energy of the first form may comprise sound waves and theenergy-transforming device 302 may include a piezo-electric element fortransforming the sound waves into electric energy. The energy of thesecond form may comprise electric energy in the form of a direct currentor pulsating direct current, or a combination of a direct current andpulsating direct current, or an alternating current or a combination ofa direct and alternating current. Normally, the apparatus compriseselectric components that are energized with electrical energy. Otherimplantable electric components of the system may be at least onevoltage level guard or at least one constant current guard connectedwith the electric components of the apparatus.

Optionally, one of the energy of the first form and the energy of thesecond form may comprise magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy or thermal energy. Preferably, one of the energy of thefirst form and the energy of the second form is non-magnetic,non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.

The energy-transmission device may be controlled from outside thepatient's body to release electromagnetic wireless energy, and thereleased electromagnetic wireless energy is used for operating theapparatus. Alternatively, the energy-transmission device is controlledfrom outside the patient's body to release non-magnetic wireless energy,and the released non-magnetic wireless energy is used for operating theapparatus.

The external energy-transmission device 304 also includes a wirelessremote control having an external signal transmitter for transmitting awireless control signal for non-invasively controlling the apparatus.The control signal is received by an implanted signal receiver which maybe incorporated in the implanted energy-transforming device 302 or beseparate there from.

The wireless control signal may include a frequency, amplitude, or phasemodulated signal or a combination thereof. Alternatively, the wirelesscontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal. Alternatively, thewireless control signal comprises an electric or magnetic field, or acombined electric and magnetic field.

The wireless remote control may transmit a carrier signal for carryingthe wireless control signal. Such a carrier signal may include digital,analogue or a combination of digital and analogue signals. Where thecontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal, the wireless remotecontrol preferably transmits an electromagnetic carrier wave signal forcarrying the digital or analogue control signals.

FIG. 20 illustrates the system of FIG. 19 in the form of a moregeneralized block diagram showing the apparatus 10, theenergy-transforming device 302 powering the apparatus 100 via powersupply line 303, and the external energy-transmission device 304, Thepatient's skin 305, generally shown by a vertical line, separates theinterior of the patient to the right of the line from the exterior tothe left of the line.

FIG. 21 shows an embodiment of the invention identical to that of FIG.20, except that a reversing device in the form of an electric switch 306operable for example by polarized energy also is implanted in thepatient for reversing the apparatus 10. When the switch is operated bypolarized energy the wireless remote control of the externalenergy-transmission device 304 transmits a wireless signal that carriespolarized energy and the implanted energy-transforming device 302transforms the wireless polarized energy into a polarized current foroperating the electric switch 306. When the polarity of the current isshifted by the implanted energy-transforming device 302 the electricswitch 1006 reverses the function performed by the apparatus 10.

FIG. 22 shows an embodiment of the invention identical to that of FIG.20, except that an operation device 307 implanted in the patient foroperating the apparatus 100 is provided between the implantedenergy-transforming device 302 and the apparatus 10. This operationdevice can be in the form of a motor 307, such as an electricservomotor. The motor 307 is powered with energy from the implantedenergy-transforming device 302, as the remote control of the externalenergy-transmission device 304 transmits a wireless signal to thereceiver of the implanted energy-transforming device 302.

FIG. 23 shows an embodiment of the invention identical to that of FIG.20, except that it also comprises an operation device is in the form ofan assembly 308 including a motor/pump unit 309 and a fluid reservoir310 is implanted in the patient. In this case the apparatus 10 ishydraulically operated, i.e. hydraulic fluid is pumped by the motor/pumpunit 309 from the fluid reservoir 310 through a conduit 311 to theapparatus 10 to operate the apparatus, and hydraulic fluid is pumped bythe motor/pump unit 309 back from the apparatus 10 to the fluidreservoir 310 to return the apparatus to a starting position. Theimplanted energy-transforming device 302 transforms wireless energy intoa current, for example a polarized current, for powering the motor/pumpunit 309 via an electric power supply line 312.

Instead of a hydraulically operated apparatus 10, it is also envisagedthat the operation device comprises a pneumatic operation device. Inthis case, the hydraulic fluid can be pressurized air to be used forregulation and the fluid reservoir is replaced by an air chamber.

In all of these embodiments the energy-transforming device 302 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the system.

As an alternative, the wireless remote control described above may bereplaced by manual control of any implanted part to make contact with bythe patient's hand most likely indirect, for example a press buttonplaced under the skin.

FIG. 24 shows an embodiment of the invention comprising the externalenergy-transmission device 304 with its wireless remote control, theapparatus 10, in this case hydraulically operated, and the implantedenergy-transforming device 302, and further comprising a hydraulic fluidreservoir 313, a motor/pump unit 309 and an reversing device in the formof a hydraulic valve shifting device 314, all implanted in the patient.Of course the hydraulic operation could easily be performed by justchanging the pumping direction and the hydraulic valve may therefore beomitted. The remote control may be a device separated from the externalenergy-transmission device or included in the same.

The motor of the motor/pump unit 309 is an electric motor. In responseto a control signal from the wireless remote control of the externalenergy-transmission device 304, the implanted energy-transforming device302 powers the motor/pump unit 309 with energy from the energy carriedby the control signal, whereby the motor/pump unit 309 distributeshydraulic fluid between the hydraulic fluid reservoir 313 and theapparatus 10. The remote control of the external energy-transmissiondevice 304 controls the hydraulic valve shifting device 314 to shift thehydraulic fluid flow direction between one direction in which the fluidis pumped by the motor/pump unit 309 from the hydraulic fluid reservoir313 to the apparatus 10 to operate the apparatus, and another oppositedirection in which the fluid is pumped by the motor/pump unit 309 backfrom the apparatus 10 to the hydraulic fluid reservoir 313 to return theapparatus to a starting position.

FIG. 25 shows an embodiment of the invention comprising the externalenergy-transmission device 304 with its wireless remote control, theapparatus 10, the implanted energy-transforming device 302, an implantedinternal control unit 315 controlled by the wireless remote control ofthe external energy-transmission device 304, an implanted accumulator316 and an implanted capacitor 317. The internal control unit 315arranges storage of electric energy received from the implantedenergy-transforming device 302 in the accumulator 316, which suppliesenergy to the apparatus 10. In response to a control signal from thewireless remote control of the external energy-transmission device 304,the internal control unit 315 either releases electric energy from theaccumulator 316 and transfers the released energy via power lines 318and 319, or directly transfers electric energy from the implantedenergy-transforming device 302 via a power line 320, the capacitor 317,which stabilizes the electric current, a power line 321 and the powerline 319, for the operation of the apparatus 10.

The internal control unit is preferably programmable from outside thepatient's body. In a preferred embodiment, the internal control unit isprogrammed to regulate the apparatus 10 according to a pre-programmedtime-schedule or to input from any sensor sensing any possible physicalparameter of the patient or any functional parameter of the system.

In accordance with an alternative, the capacitor 317 in the embodimentof FIG. 25 may be omitted. In accordance with another alternative, theaccumulator 316 in this embodiment may be omitted.

FIG. 26 shows an embodiment of the invention identical to that of FIG.20, except that a battery 322 for supplying energy for the operation ofthe apparatus 10 and an electric switch 323 for switching the operationof the apparatus 10 also are implanted in the patient. The electricswitch 323 may be controlled by the remote control and may also beoperated by the energy supplied by the implanted energy-transformingdevice 302 to switch from an off mode, in which the battery 322 is notin use, to an on mode, in which the battery 322 supplies energy for theoperation of the apparatus 10.

FIG. 27 shows an embodiment of the invention identical to that of FIG.26, except that an internal control unit 315 controllable by thewireless remote control of the external energy-transmission device 304also is implanted in the patient. In this case, the electric switch 323is operated by the energy supplied by the implanted energy-transformingdevice 302 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the internal control unit 315 andthe battery is not in use, to a standby mode, in which the remotecontrol is permitted to control the internal control unit 315 to releaseelectric energy from the battery 322 for the operation of the apparatus10.

FIG. 28 shows an embodiment of the invention identical to that of FIG.27, except that an accumulator 316 is substituted for the battery 322and the implanted components are interconnected differently. In thiscase, the accumulator 316 stores energy from the implantedenergy-transforming device 302. In response to a control signal from thewireless remote control of the external energy-transmission device 304,the internal control unit 315 controls the electric switch 323 to switchfrom an off mode, in which the accumulator 316 is not in use, to an onmode, in which the accumulator 316 supplies energy for the operation ofthe apparatus 10. The accumulator may be combined with or replaced by acapacitor.

FIG. 29 shows an embodiment of the invention identical to that of FIG.28, except that a battery 322 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 304, the internal control unit 315 controlsthe accumulator 316 to deliver energy for operating the electric switch323 to switch from an off mode, in which the battery 322 is not in use,to an on mode, in which the battery 322 supplies electric energy for theoperation of the apparatus 10.

Alternatively, the electric switch 323 may be operated by energysupplied by the accumulator 316 to switch from an off mode, in which thewireless remote control is prevented from controlling the battery 322 tosupply electric energy and is not in use, to a standby mode, in whichthe wireless remote control is permitted to control the battery 322 tosupply electric energy for the operation of the apparatus 10.

It should be understood that the switch 323 and all other switches inthis application should be interpreted in its broadest embodiment. Thismeans a transistor, MCU, MCPU, ASIC, FPGA or a DA converter or any otherelectronic component or circuit that may switch the power on and off.Preferably the switch is controlled from outside the body, oralternatively by an implanted internal control unit.

FIG. 30 shows an embodiment of the invention identical to that of FIG.26, except that a motor 307, a mechanical reversing device in the formof a gear box 324, and an internal control unit 315 for controlling thegear box 324 also are implanted in the patient. The internal controlunit 315 controls the gear box 324 to reverse the function performed bythe apparatus 10 (mechanically operated). Even simpler is to switch thedirection of the motor electronically. The gear box interpreted in itsbroadest embodiment may stand for a servo arrangement saving force forthe operation device in favour of longer stroke to act.

FIG. 31 shows an embodiment of the invention identical to that of FIG.27 except that the implanted components are interconnected differently.Thus, in this case the internal control unit 315 is powered by thebattery 322 when the accumulator 316, suitably a capacitor, activatesthe electric switch 323 to switch to an on mode. When the electricswitch 323 is in its on mode the internal control unit 315 is permittedto control the battery 322 to supply, or not supply, energy for theoperation of the apparatus 10.

FIG. 32 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communication options.Basically, there are the apparatus 10, the internal control unit 315,motor or pump unit 309, and the external energy-transmission device 304including the external wireless remote control. As already describedabove the wireless remote control transmits a control signal which isreceived by the internal control unit 315, which in turn controls thevarious implanted components of the apparatus.

A feedback device, preferably comprising a sensor or measuring device325, may be implanted in the patient for sensing a physical parameter ofthe patient. The physical parameter may be at least one selected fromthe group consisting of pressure, volume, diameter, stretching,elongation, extension, movement, bending, elasticity, musclecontraction, nerve impulse, body temperature, blood pressure, bloodflow, heartbeats and breathing. The sensor may sense any of the abovephysical parameters. For example, the sensor may be a pressure ormotility sensor. Alternatively, the sensor 325 may be arranged to sensea functional parameter. The functional parameter may be correlated tothe transfer of energy for charging an implanted energy source and mayfurther include at least one selected from the group of parametersconsisting of; electricity, any electrical parameter, pressure, volume,diameter, stretch, elongation, extension, movement, bending, elasticity,temperature and flow.

The feedback may be sent to the internal control unit or out to anexternal control unit preferably via the internal control unit. Feedbackmay be sent out from the body via the energy transfer system or aseparate communication system with receiver and transmitters.

The internal control unit 315, or alternatively the external wirelessremote control of the external energy-transmission device 304, maycontrol the apparatus 10 in response to signals from the sensor 325. Atransceiver may be combined with the sensor 325 for sending informationon the sensed physical parameter to the external wireless remotecontrol. The wireless remote control may comprise a signal transmitteror transceiver and the internal control unit 315 may comprise a signalreceiver or transceiver. Alternatively, the wireless remote control maycomprise a signal receiver or transceiver and the internal control unit315 may comprise a signal transmitter or transceiver. The abovetransceivers, transmitters and receivers may be used for sendinginformation or data related to the apparatus 10 from inside thepatient's body to the outside thereof.

Where the motor/pump unit 309 and battery 322 for powering themotor/pump unit 309 are implanted, information related to the chargingof the battery 322 may be fed back. To be more precise, when charging abattery or accumulator with energy feed back information related to saidcharging process is sent and the energy supply is changed accordingly.

FIG. 33 shows an alternative embodiment wherein the apparatus 10 isregulated from outside the patient's body. The system 300 comprises abattery 322 connected to the apparatus 10 via a subcutaneous electricswitch 326. Thus, the regulation of the apparatus 10 is performednon-invasively by manually pressing the subcutaneous switch, whereby theoperation of the apparatus 10 is switched on and off. It will beappreciated that the shown embodiment is a simplification and thatadditional components, such as an internal control unit or any otherpart disclosed in the present application can be added to the system.Two subcutaneous switches may also be used. In the preferred embodimentone implanted switch sends information to the internal control unit toperform a certain predetermined performance and when the patient pressthe switch again the performance is reversed.

FIG. 34 shows an alternative embodiment, wherein the system 300comprises a hydraulic fluid reservoir 313 hydraulically connected to theapparatus. Non-invasive regulation is performed by manually pressing thehydraulic reservoir connected to the apparatus.

The system may include an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator. The internal communicator feeds data related to theapparatus or the patient to the external data communicator and/or theexternal data communicator feeds data to the internal data communicator.

FIG. 35 schematically illustrates an arrangement of the system that iscapable of sending information from inside the patient's body to theoutside thereof to give feedback information related to at least onefunctional parameter of the apparatus or system, or related to aphysical parameter of the patient, in order to supply an accurate amountof energy to an implanted internal energy receiver 302 connected toimplanted energy consuming components of the apparatus 10. Such anenergy receiver 302 may include an energy source and/or anenergy-transforming device. Briefly described, wireless energy istransmitted from an external energy source 304 a located outside thepatient and is received by the internal energy receiver 302 locatedinside the patient.

The internal energy receiver is adapted to directly or indirectly supplyreceived energy to the energy consuming components of the apparatus 10via a switch 326. An energy balance is determined between the energyreceived by the internal energy receiver 302 and the energy used for theapparatus 10, and the transmission of wireless energy is then controlledbased on the determined energy balance. The energy balance thus providesan accurate indication of the correct amount of energy needed, which issufficient to operate the apparatus 10 properly, but without causingundue temperature rise.

In FIG. 35 the patient's skin is indicated by a vertical line 305. Here,the energy receiver comprises an energy-transforming device 302 locatedinside the patient, preferably just beneath the patient's skin 305.Generally speaking, the implanted energy-transforming device 302 may beplaced in the abdomen, thorax, muscle fascia (e.g. in the abdominalwall), subcutaneously, or at any other suitable location. The implantedenergy-transforming device 302 is adapted to receive wireless energy Etransmitted from the external energy-source 304 a provided in anexternal energy-transmission device 304 located outside the patient'sskin 305 in the vicinity of the implanted energy-transforming device302.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal energy source 304 a and an adjacent secondary coil arranged inthe implanted energy-transforming device 302. When an electric currentis fed through the primary coil, energy in the form of a voltage isinduced in the secondary coil which can be used to power the implantedenergy consuming components of the apparatus, e.g. after storing theincoming energy in an implanted energy source, such as a rechargeablebattery or a capacitor. However, the present invention is generally notlimited to any particular energy transfer technique, TET devices orenergy sources, and any kind of wireless energy may be used.

The amount of energy received by the implanted energy receiver may becompared with the energy used by the implanted components of theapparatus. The term “energy used” is then understood to include alsoenergy stored by implanted components of the apparatus. A control deviceincludes an external control unit 304 b that controls the externalenergy source 304 a based on the determined energy balance to regulatethe amount of transferred energy. In order to transfer the correctamount of energy, the energy balance and the required amount of energyis determined by means of a determination device including an implantedinternal control unit 315 connected between the switch 326 and theapparatus 10.

The internal control unit 315 may thus be arranged to receive variousmeasurements obtained by suitable sensors or the like, not shown,measuring certain characteristics of the apparatus 10, somehowreflecting the required amount of energy needed for proper operation ofthe apparatus 10. Moreover, the current condition of the patient mayalso be detected by means of suitable measuring devices or sensors, inorder to provide parameters reflecting the patient's condition. Hence,such characteristics and/or parameters may be related to the currentstate of the apparatus 10, such as power consumption, operational modeand temperature, as well as the patient's condition reflected byparameters such as; body temperature, blood pressure, heartbeats andbreathing. Other kinds of physical parameters of the patient andfunctional parameters of the device are described elsewhere.

Furthermore, an energy source in the form of an accumulator 316 mayoptionally be connected to the implanted energy-transforming device 302via the control unit 315 for accumulating received energy for later useby the apparatus 10. Alternatively or additionally, characteristics ofsuch an accumulator, also reflecting the required amount of energy, maybe measured as well. The accumulator may be replaced by a rechargeablebattery, and the measured characteristics may be related to the currentstate of the battery, any electrical parameter such as energyconsumption voltage, temperature, etc. In order to provide sufficientvoltage and current to the apparatus 10, and also to avoid excessiveheating, it is clearly understood that the battery should be chargedoptimally by receiving a correct amount of energy from the implantedenergy-transforming device 302, i.e. not too little or too much. Theaccumulator may also be a capacitor with corresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 315. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 315 of the determination device isadapted to determine the energy balance and/or the currently requiredamount of energy, (either energy per time unit or accumulated energy)based on measurements made by the above-mentioned sensors or measuringdevices of the apparatus 10, or the patient, or an implanted energysource if used, or any combination thereof. The internal control unit315 is further connected to an internal signal transmitter 327, arrangedto transmit a control signal reflecting the determined required amountof energy, to an external signal receiver 304 c connected to theexternal control unit 304 b. The amount of energy transmitted from theexternal energy source 304 a may then be regulated in response to thereceived control signal.

Alternatively, the determination device may include the external controlunit 304 b. In this alternative, sensor measurements can be transmitteddirectly to the external control unit 304 b wherein the energy balanceand/or the currently required amount of energy can be determined by theexternal control unit 304 b, thus integrating the above-describedfunction of the internal control unit 315 in the external control unit304 b. In that case, the internal control unit 315 can be omitted andthe sensor measurements are supplied directly to the internal signaltransmitter 327 which sends the measurements over to the external signalreceiver 304 c and the external control unit 304 b. The energy balanceand the currently required amount of energy can then be determined bythe external control unit 304 b based on those sensor measurements.

Hence, the present solution according to the arrangement of FIG. 35employs the feedback of information indicating the required energy,which is more efficient than previous solutions because it is based onthe actual use of energy that is compared to the received energy, e.g.with respect to the amount of energy, the energy difference, or theenergy receiving rate as compared to the energy rate used by implantedenergy consuming components of the apparatus. The apparatus may use thereceived energy either for consuming or for storing the energy in animplanted energy source or the like. The different parameters discussedabove would thus be used if relevant and needed and then as a tool fordetermining the actual energy balance. However, such parameters may alsobe needed per se for any actions taken internally to specificallyoperate the apparatus.

The internal signal transmitter 327 and the external signal receiver 304c may be implemented as separate units using suitable signal transfermeans, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 327 and the externalsignal receiver 304 c may be integrated in the implantedenergy-transforming device 302 and the external energy source 304 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

Thus, the feedback information may be transferred either by a separatecommunication system including receivers and transmitters or may beintegrated in the energy system. In accordance with the presentinvention, such an integrated information feedback and energy systemcomprises an implantable internal energy receiver for receiving wirelessenergy, the energy receiver having an internal first coil and a firstelectronic circuit connected to the first coil, and an external energytransmitter for transmitting wireless energy, the energy transmitterhaving an external second coil and a second electronic circuit connectedto the second coil. The external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver. This system further comprises a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off. Inimplementing this system in the arrangement of FIG. 17, the switch 326is either separate and controlled by the internal control unit 315, orintegrated in the internal control unit 315. It should be understoodthat the switch 326 should be interpreted in its broadest embodiment.This means a transistor, MCU, MCPU, ASIC FPGA or a DA converter or anyother electronic component or circuit that may switch the power on andoff.

To conclude, the energy supply arrangement illustrated in FIG. 35 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 315 of the determination device.A control signal reflecting the required amount of energy is alsocreated by the internal control unit 315, and the control signal istransmitted from the internal signal transmitter 327 to the externalsignal receiver 304 c. Alternatively, the energy balance can bedetermined by the external control unit 304 b instead depending on theimplementation, as mentioned above. In that case, the control signal maycarry measurement results from various sensors. The amount of energyemitted from the external energy source 304 a can then be regulated bythe external control unit 304 b, based on the determined energy balance,e.g. in response to the received control signal. This process may berepeated intermittently at certain intervals during ongoing energytransfer, or may be executed on a more or less continuous basis duringthe energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external energy source 304 a,such as voltage, current, amplitude, wave frequency and pulsecharacteristics.

This system may also be used to obtain information about the couplingfactors between the coils in a TET system even to calibrate the systemboth to find an optimal place for the external coil in relation to theinternal coil and to optimize energy transfer. Simply comparing in thiscase the amount of energy transferred with the amount of energyreceived. For example if the external coil is moved the coupling factormay vary and correctly displayed movements could cause the external coilto find the optimal place for energy transfer. Preferably, the externalcoil is adapted to calibrate the amount of transferred energy to achievethe feedback information in the determination device, before thecoupling factor is maximized.

This coupling factor information may also be used as a feedback duringenergy transfer. In such a case, the energy system of the presentinvention comprises an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil. The external second coil of theenergy transmitter transmits wireless energy which is received by thefirst coil of the energy receiver. This system further comprises afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorbetween the first and second coils. The energy transmitter may regulatethe transmitted energy in response to the obtained coupling factor.

With reference to FIG. 36, although wireless transfer of energy foroperating the apparatus has been described above to enable non-invasiveoperation, it will be appreciated that the apparatus can be operatedwith wire bound energy as well. Such an example is shown in FIG. 18,wherein an external switch 326 is interconnected between the externalenergy source 304 a and an operation device, such as an electric motor307 operating the apparatus 10. An external control unit 304 b controlsthe operation of the external switch 326 to effect proper operation ofthe apparatus 10.

FIG. 37 illustrates different embodiments for how received energy can besupplied to and used by the apparatus 10. Similar to the example of FIG.17, an internal energy receiver 302 receives wireless energy E from anexternal energy source 304 a which is controlled by a transmissioncontrol unit 304 b. The internal energy receiver 302 may comprise aconstant voltage circuit, indicated as a dashed box “constant V” in thefigure, for supplying energy at constant voltage to the apparatus 10.The internal energy receiver 302 may further comprise a constant currentcircuit, indicated as a dashed box “constant C” in the figure, forsupplying energy at constant current to the apparatus 10.

The apparatus 10 comprises an energy consuming part 10 a, which may be amotor, pump, restriction device, or any other medical appliance thatrequires energy for its electrical operation. The apparatus 10 mayfurther comprise an energy storage device 10 b for storing energysupplied from the internal energy receiver 302. Thus, the suppliedenergy may be directly consumed by the energy consuming part 10 a, orstored by the energy storage device 10 b, or the supplied energy may bepartly consumed and partly stored. The apparatus 10 may further comprisean energy stabilizing unit 10 c for stabilizing the energy supplied fromthe internal energy receiver 302. Thus, the energy may be supplied in afluctuating manner such that it may be necessary to stabilize the energybefore consumed or stored.

The energy supplied from the internal energy receiver 302 may further beaccumulated and/or stabilized by a separate energy stabilizing unit 328located outside the apparatus 10, before being consumed and/or stored bythe apparatus 10. Alternatively, the energy stabilizing unit 328 may beintegrated in the internal energy receiver 302. In either case, theenergy stabilizing unit 328 may comprise a constant voltage circuitand/or a constant current circuit.

It should be noted that FIG. 35 and FIG. 36 illustrate some possible butnon-limiting implementation options regarding how the various shownfunctional components and elements can be arranged and connected to eachother. However, the skilled person will readily appreciate that manyvariations and modifications can be made within the scope of the presentinvention.

FIG. 38 schematically shows an energy balance measuring circuit of oneof the proposed designs of the system for controlling transmission ofwireless energy, or energy balance control system. The circuit has anoutput signal centered on 2.5V and proportionally related to the energyimbalance. The derivative of this signal shows if the value goes up anddown and how fast such a change takes place. If the amount of receivedenergy is lower than the energy used by implanted components of theapparatus, more energy is transferred and thus charged into the energysource. The output signal from the circuit is typically feed to an NDconverter and converted into a digital format. The digital informationcan then be sent to the external energy-transmission device allowing itto adjust the level of the transmitted energy. Another possibility is tohave a completely analog system that uses comparators comparing theenergy balance level with certain maximum and minimum thresholds sendinginformation to external energy-transmission device if the balance driftsout of the max/min window.

The schematic FIG. 38 shows a circuit implementation for a system thattransfers energy to the implanted energy components of the apparatus ofthe present invention from outside of the patient's body using inductiveenergy transfer. An inductive energy transfer system typically uses anexternal transmitting coil and an internal receiving coil. The receivingcoil, L1, is included in the schematic FIG. 21; the transmitting partsof the system are excluded.

The implementation of the general concept of energy balance and the waythe information is transmitted to the external energy transmitter can ofcourse be implemented in numerous different ways. The schematic FIG. 38and the above described method of evaluating and transmitting theinformation should only be regarded as examples of how to implement thecontrol system.

Circuit Details

In FIG. 38 the symbols Y1, Y2, Y3 and so on symbolize test points withinthe circuit. The components in the diagram and their respective valuesare values that work in this particular implementation which of courseis only one of an infinite number of possible design solutions.

Energy to power the circuit is received by the energy receiving coil L1.Energy to implanted components is transmitted in this particular case ata frequency of 25 kHz. The energy balance output signal is present attest point Y1.

Those skilled in the art will realize that the above various embodimentsof the system could be combined in many different ways. For example, theelectric switch 306 of FIG. 21 could be incorporated in any of theembodiments of FIGS. 24-30, the hydraulic valve shifting device 314 ofFIG. 24 could be incorporated in the embodiment of FIG. 23, and the gearbox 324 could be incorporated in the embodiment of FIG. 22. Pleaseobserve that the switch simply could mean any electronic circuit orcomponent.

The embodiments described in connection with FIGS. 35, 37 and 38identify a method and a system for controlling transmission of wirelessenergy to implanted energy consuming components of an electricallyoperable apparatus. Such a method and system will be defined in generalterms in the following.

A method is thus provided for controlling transmission of wirelessenergy supplied to implanted energy consuming components of an apparatusas described above. The wireless energy E is transmitted from anexternal energy source located outside the patient and is received by aninternal energy receiver located inside the patient, the internal energyreceiver being connected to the implanted energy consuming components ofthe apparatus for directly or indirectly supplying received energythereto. An energy balance is determined between the energy received bythe internal energy receiver and the energy used for the apparatus. Thetransmission of wireless energy E from the external energy source isthen controlled based on the determined energy balance.

The wireless energy may be transmitted inductively from a primary coilin the external energy source to a secondary coil in the internal energyreceiver. A change in the energy balance may be detected to control thetransmission of wireless energy based on the detected energy balancechange. A difference may also be detected between energy received by theinternal energy receiver and energy used for the medical device, tocontrol the transmission of wireless energy based on the detected energydifference.

When controlling the energy transmission, the amount of transmittedwireless energy may be decreased if the detected energy balance changeimplies that the energy balance is increasing, or vice versa. Thedecrease/increase of energy transmission may further correspond to adetected change rate.

The amount of transmitted wireless energy may further be decreased ifthe detected energy difference implies that the received energy isgreater than the used energy, or vice versa. The decrease/increase ofenergy transmission may then correspond to the magnitude of the detectedenergy difference.

As mentioned above, the energy used for the medical device may beconsumed to operate the medical device, and/or stored in at least oneenergy storage device of the medical device.

When electrical and/or physical parameters of the medical device and/orphysical parameters of the patient are determined, the energy may betransmitted for consumption and storage according to a transmission rateper time unit which is determined based on said parameters. The totalamount of transmitted energy may also be determined based on saidparameters.

When a difference is detected between the total amount of energyreceived by the internal energy receiver and the total amount ofconsumed and/or stored energy, and the detected difference is related tothe integral over time of at least one measured electrical parameterrelated to said energy balance, the integral may be determined for amonitored voltage and/or current related to the energy balance.

When the derivative is determined over time of a measured electricalparameter related to the amount of consumed and/or stored energy, thederivative may be determined for a monitored voltage and/or currentrelated to the energy balance.

The transmission of wireless energy from the external energy source maybe controlled by applying to the external energy source electricalpulses from a first electric circuit to transmit the wireless energy,the electrical pulses having leading and trailing edges, varying thelengths of first time intervals between successive leading and trailingedges of the electrical pulses and/or the lengths of second timeintervals between successive trailing and leading edges of theelectrical pulses, and transmitting wireless energy, the transmittedenergy generated from the electrical pulses having a varied power, thevarying of the power depending on the lengths of the first and/or secondtime intervals.

In that case, the frequency of the electrical pulses may besubstantially constant when varying the first and/or second timeintervals. When applying electrical pulses, the electrical pulses mayremain unchanged, except for varying the first and/or second timeintervals. The amplitude of the electrical pulses may be substantiallyconstant when varying the first and/or second time intervals. Further,the electrical pulses may be varied by only varying the lengths of firsttime intervals between successive leading and trailing edges of theelectrical pulses.

A train of two or more electrical pulses may be supplied in a row,wherein when applying the train of pulses, the train having a firstelectrical pulse at the start of the pulse train and having a secondelectrical pulse at the end of the pulse train, two or more pulse trainsmay be supplied in a row, wherein the lengths of the second timeintervals between successive trailing edge of the second electricalpulse in a first pulse train and leading edge of the first electricalpulse of a second pulse train are varied.

When applying the electrical pulses, the electrical pulses may have asubstantially constant current and a substantially constant voltage. Theelectrical pulses may also have a substantially constant current and asubstantially constant voltage. Further, the electrical pulses may alsohave a substantially constant frequency. The electrical pulses within apulse train may likewise have a substantially constant frequency.

The circuit formed by the first electric circuit and the external energysource may have a first characteristic time period or first timeconstant, and when effectively varying the transmitted energy, suchfrequency time period may be in the range of the first characteristictime period or time constant or shorter.

A system comprising an apparatus as described above is thus alsoprovided for controlling transmission of wireless energy supplied toimplanted energy consuming components of the apparatus. In its broadestsense, the system comprises a control device for controlling thetransmission of wireless energy from an energy-transmission device, andan implantable internal energy receiver for receiving the transmittedwireless energy, the internal energy receiver being connected toimplantable energy consuming components of the apparatus for directly orindirectly supplying received energy thereto. The system furthercomprises a determination device adapted to determine an energy balancebetween the energy received by the internal energy receiver and theenergy used for the implantable energy consuming components of theapparatus, wherein the control device controls the transmission ofwireless energy from the external energy-transmission device, based onthe energy balance determined by the determination device.

Further, the system may comprise any of the following:

-   -   A primary coil in the external energy source adapted to transmit        the wireless energy inductively to a secondary coil in the        internal energy receiver.    -   The determination device is adapted to detect a change in the        energy balance, and the control device controls the transmission        of wireless energy based on the detected energy balance change    -   The determination device is adapted to detect a difference        between energy received by the internal energy receiver and        energy used for the implantable energy consuming components of        the apparatus, and the control device controls the transmission        of wireless energy based on the detected energy difference.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy balance change implies that the energy        balance is increasing, or vice versa, wherein the        decrease/increase of energy transmission corresponds to a        detected change rate.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy difference implies that the received energy        is greater than the used energy, or vice versa, wherein the        decrease/increase of energy transmission corresponds to the        magnitude of said detected energy difference.    -   The energy used for the apparatus is consumed to operate the        apparatus, and/or stored in at least one energy storage device        of the apparatus.    -   Where electrical and/or physical parameters of the apparatus        and/or physical parameters of the patient are determined, the        energy-transmission device transmits the energy for consumption        and storage according to a transmission rate per time unit which        is determined by the determination device based on said        parameters. The determination device also determines the total        amount of transmitted energy based on said parameters.    -   When a difference is detected between the total amount of energy        received by the internal energy receiver and the total amount of        consumed and/or stored energy, and the detected difference is        related to the integral over time of at least one measured        electrical parameter related to the energy balance, the        determination device determines the integral for a monitored        voltage and/or current related to the energy balance.    -   When the derivative is determined over time of a measured        electrical parameter related to the amount of consumed and/or        stored energy, the determination device determines the        derivative for a monitored voltage and/or current related to the        energy balance.    -   The energy-transmission device comprises a coil placed        externally to the human body, and an electric circuit is        provided to power the external coil with electrical pulses to        transmit the wireless energy. The electrical pulses have leading        and trailing edges, and the electric circuit is adapted to vary        first time intervals between successive leading and trailing        edges and/or second time intervals between successive trailing        and leading edges of the electrical pulses to vary the power of        the transmitted wireless energy. As a result, the energy        receiver receiving the transmitted wireless energy has a varied        power.    -   The electric circuit is adapted to deliver the electrical pulses        to remain unchanged except varying the first and/or second time        intervals.    -   The electric circuit has a time constant and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the coil is varied.    -   The electric circuit is adapted to deliver the electrical pulses        to be varied by only varying the lengths of first time intervals        between successive leading and trailing edges of the electrical        pulses.    -   The electric circuit is adapted to supplying a train of two or        more electrical pulses in a row, said train having a first        electrical pulse at the start of the pulse train and having a        second electrical pulse at the end of the pulse train, and    -   the lengths of the second time intervals between successive        trailing edge of the second electrical pulse in a first pulse        train and leading edge of the first electrical pulse of a second        pulse train are varied by the first electronic circuit.    -   The electric circuit is adapted to provide the electrical pulses        as pulses having a substantially constant height and/or        amplitude and/or intensity and/or voltage and/or current and/or        frequency.    -   The electric circuit has a time constant, and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the first coil are varied.    -   The electric circuit is adapted to provide the electrical pulses        varying the lengths of the first and/or the second time        intervals only within a range that includes the first time        constant or that is located relatively close to the first time        constant, compared to the magnitude of the first time constant.

FIGS. 39-42 show in more detail block diagrams of four different ways ofhydraulically or pneumatically powering an implanted apparatus accordingto the invention.

FIG. 39 shows a system as described above with. The system comprises animplanted apparatus 10 and further a separate regulation reservoir 1013,a one way pump 1009 and an alternate valve 1014.

FIG. 40 shows the apparatus 10 and a fluid reservoir 1013. By moving thewall of the regulation reservoir or changing the size of the same in anyother different way, the adjustment of the apparatus may be performedwithout any valve, just free passage of fluid any time by moving thereservoir wall.

FIG. 41 shows the apparatus 10, a two way pump 1009 and the regulationreservoir 1013.

FIG. 42 shows a block diagram of a reversed servo system with a firstclosed system controlling a second closed system. The servo systemcomprises a regulation reservoir 1013 and a servo reservoir 1050. Theservo reservoir 1050 mechanically controls an implanted apparatus 10 viaa mechanical interconnection 1054. The apparatus has anexpandable/contactable cavity. This cavity is preferably expanded orcontracted by supplying hydraulic fluid from the larger adjustablereservoir 1052 in fluid connection with the apparatus 10. Alternatively,the cavity contains compressible gas, which can be compressed andexpanded under the control of the servo reservoir 1050. The servoreservoir 1050 can also be part of the apparatus itself.

In one embodiment, the regulation reservoir is placed subcutaneous underthe patient's skin and is operated by pushing the outer surface thereofby means of a finger. This system is illustrated in FIGS. 43a-c . InFIG. 43a , a flexible subcutaneous regulation reservoir 1013 is shownconnected to a bulge shaped servo reservoir 1050 by means of a conduit1011. This bellow shaped servo reservoir 1050 is comprised in a flexibleapparatus 10. In the state shown in FIG. 43a , the servo reservoir 1050contains a minimum of fluid and most fluid is found in the regulationreservoir 1013. Due to the mechanical interconnection between the servoreservoir 1050 and the apparatus 10, the outer shape of the apparatus 10is contracted, i.e., it occupies less than its maximum volume. Thismaximum volume is shown with dashed lines in the figure.

FIG. 43b shows a state wherein a user, such as the patient in with theapparatus is implanted, presses the regulation reservoir 1013 so thatfluid contained therein is brought to flow through the conduit 1011 andinto the servo reservoir 1050, which, thanks to its bellow shape,expands longitudinally. This expansion in turn expands the apparatus 10so that it occupies its maximum volume, thereby stretching the stomachwall (not shown), which it contacts.

The regulation reservoir 1013 is preferably provided with means 1013 afor keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the apparatus 10 in astretched position also when the user releases the regulation reservoir.In this way, the regulation reservoir essentially operates as an on/offswitch for the system.

An alternative embodiment of hydraulic or pneumatic operation will nowbe described with reference to FIGS. 44 and 45 a-c. The block diagramshown in FIG. 44 comprises with a first closed system controlling asecond closed system. The first system comprises a regulation reservoir1013 and a servo reservoir 1050. The servo reservoir 1050 mechanicallycontrols a larger adjustable reservoir 1052 via a mechanicalinterconnection 1054. An implanted apparatus 10 having anexpandable/contactable cavity is in turn controlled by the largeradjustable reservoir 1052 by supply of hydraulic fluid from the largeradjustable reservoir 1052 in fluid connection with the apparatus 10.

An example of this embodiment will now be described with reference toFIG. 45a-c . Like in the previous embodiment, the regulation reservoiris placed subcutaneous under the patient's skin and is operated bypushing the outer surface thereof by means of a finger. The regulationreservoir 1013 is in fluid connection with a bellow shaped servoreservoir 1050 by means of a conduit 1011. In the first closed system1013, 1011, 1050 shown in FIG. 45a , the servo reservoir 1050 contains aminimum of fluid and most fluid is found in the regulation reservoir1013.

The servo reservoir 1050 is mechanically connected to a largeradjustable reservoir 1052, in this example also having a bellow shapebut with a larger diameter than the servo reservoir 1050. The largeradjustable reservoir 1052 is in fluid connection with the apparatus 10.This means that when a user pushes the regulation reservoir 1013,thereby displacing fluid from the regulation reservoir 1013 to the servoreservoir 1050, the expansion of the servo reservoir 1050 will displacea larger volume of fluid from the larger adjustable reservoir 1052 tothe apparatus 10. In other words, in this reversed servo, a small volumein the regulation reservoir is compressed with a higher force and thiscreates a movement of a larger total area with less force per area unit.

Like in the previous embodiment described above with reference to FIGS.43a-c , the regulation reservoir 1013 is preferably provided with means1013 a for keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the apparatus 10 in astretched position also when the user releases the regulation reservoir.In this way, the regulation reservoir essentially operates as an on/offswitch for the system.

FIG. 46 shows a system of the invention, with the skin of a patientbeing shown as “S”, and with an apparatus 30 of the invention beingimplanted into a patient, “Int”, and with other details on the outsideof the patient, “Ext”

Besides the apparatus 30, the implanted equipment comprises an energytransforming device 302 as described above, a battery 1022 and, as analternative or complement, an accumulator 1016, with both the energytransforming device and the battery/accumulator being controlled by thecontrol device 1015.

The “external equipment” comprises a remote control, which is shown aspossibly comprising two parts, i.e. a transmitter or transceiver fortransmitting and possibly receiving energy to/from the device 302, and aremote control I, which may be integrated into one physical unittogether with the transmitter or transceiver.

The invention also discloses a method as follows:

A. A method of surgically placing a valve of the invention in apatient's heart or blood vessel via a laparoscopic thoracic approach,the method comprising the steps of:

-   -   inserting a needle or a tube like instrument into the thorax of        the patient's body,    -   using the needle or a tube like instrument to fill the thorax        with gas thereby expanding the thoracic cavity,    -   placing at least two laparoscopic trocars in the patient's body,    -   inserting a camera through one of the laparoscopic trocars into        the thorax,    -   inserting at least one dissecting tool through one of said at        least two laparoscopic trocars and dissecting an intended        placement area of the patient,    -   placing the valve in any part of the blood stream in the thorax,        and    -   placing and connecting an implanted energy receiver or source of        energy for powering the valve to perform at least one of the        following method steps;    -   at least partly closing and at least partly opening of the        valve.

B. An operation method for surgically placing a valve of the inventionin a patient's heart or blood vessel, the method comprising the stepsof:

-   -   cutting the patient's skin,    -   opening the thoracic cavity,    -   dissecting a placement area where to place the valve inside a        blood stream in the heart, or the aorta or inside the pulmonary        artery of the human patient,    -   placing the a valve in the placement area in any part of the        blood stream in the thorax, and    -   placing and connecting an implanted energy receiver or a source        of energy for powering the valve to perform at least one of the        following method steps;    -   at least partly closing and at least partly opening of the        valve.

C. A method of surgically placing a valve of the invention in apatient's heart or blood vessel via a laparoscopic abdominal approach,the method comprising the steps of:

-   -   inserting a needle or a tube like instrument into the abdomen of        the patient's body,    -   using the needle or a tube like instrument to fill the thorax        with gas thereby expanding the abdominal cavity,    -   placing at least two laparoscopic trocars in the patient's        abdomen    -   inserting a camera through one of the laparoscopic trocars into        the abdomen,    -   inserting at least one dissecting tool through one of said at        least two laparoscopic trocars and    -   dissecting and creating an opening in the diaphragm muscle,    -   dissecting an intended placement area of the patient through        said opening,    -   placing the valve in any part of the blood stream in the thorax,        and    -   placing and connecting an implanted energy receiver or source of        energy for powering the valve to perform at least one of the        following method steps;    -   at least partly closing and at least partly opening of the        valve.

D. An operation method for surgically placing a valve of the inventionin a patient's heart or blood vessel, the method comprising the stepsof:

-   -   cutting the patient's skin,    -   opening the abdominal cavity,    -   dissecting and creating an opening in the diaphragm muscle,    -   dissecting a placement area where to place the valve inside a        blood stream in the heart, or the aorta or inside the pulmonary        artery of the human patient through said opening,    -   placing the a valve in the placement area, and    -   placing and connecting an implanted energy receiver or a source        of energy for powering the valve to perform at least one of the        following method steps;    -   at least partly closing and at least partly opening of the        valve.

E. An operation method for surgically placing a valve of the inventionin a patient's heart or blood vessel, via inguinal key-hole surgeryapproach, the method comprising the steps of:

-   -   cutting the patients skin,    -   inserting a needle or a tube like instrument into the inguinal        area of the patient's body,    -   using the needle or a tube like instrument to fill a cavity with        gas thereby expanding the cavity,    -   placing at least two laparoscopic trocars in the patient's        cavity    -   inserting a camera through one of the trocars into the cavity,    -   inserting at least one dissecting tool through one of said at        least two trocars and    -   dissecting the area of the femoral artery,    -   inserting a tube like instrument into the femoral artery of the        patient's body,    -   inserting said valve into the femoral artery,    -   using said instrument to guide said valve through the femoral        artery to the aorta or heart of the patient,    -   releasing the valve inside of a blood vessel or heart    -   placing said valve in the blood vessel or heart,    -   placing and connecting an implanted energy receiver or a source        of energy for powering the valve to perform at least one of the        following method steps;    -   at least partly closing and at least partly opening of the        valve.

F. An operation method for surgically placing a valve of the inventionin a patient's heart or blood vessel, via a inguinal approach, themethod comprising the steps of:

-   -   cutting the patients skin,    -   dissecting the inguinal region,    -   dissecting the area of the femoral artery,    -   inserting a tube like instrument into the femoral artery of the        patient's body,    -   using said instrument to guide said rotating body through the        femoral artery and the aorta to the blood vessel or heart,    -   releasing the valve inside of the heart or blood vessel,    -   placing said valve in the blood vessel or heart,    -   placing and connecting an implanted energy receiver or a source        of energy for powering the valve to perform at least one of the        following method steps;    -   at least partly closing and at least partly opening of the        valve.

G. In one embodiment of the invention according to any of items A-F, thestep of placing the valve additionally comprises the step of:

-   -   placing a drive unit for at least partly powering the valve        movements in the placement area, inside the blood stream of the        blood vessel, inside the heart, or the aorta or inside the        pulmonary artery of the patient,    -   supplying energy from said drive unit to said valve causing        movement of said valve.

H. In one embodiment of the invention according to any of items A-F, thestep of placing the valve additionally comprises the step of:

-   -   placing a drive unit for at least partly powering the valve        movements in the placement area, outside the blood stream of the        blood vessel, outside the heart, or the aorta or outside the        pulmonary artery of the patient, placing said drive unit on the        outside of said valve,    -   supplying energy from said drive unit to said valve causing        movement of said valve.

I. In one embodiment of the invention according to items I or H, thestep of supplying energy from said drive unit to said valve, causingmovement of said valve, additionally comprises the step of:

-   -   supplying wireless or magnetic energy from said drive unit to        said valve, causing movement of said valve.

J. In one embodiment of the invention according to any of items G-I, themethod additionally comprises the step of:

-   -   connecting the drive unit with the energy receiver or source of        energy for powering said drive unit.

K. In one embodiment of the invention according to any of items A-D andH, for parts of the valve placed outside the blood stream, combiningwith the method according to one or more of claims E-G for parts of thevalve placed inside the blood stream.

L. In one embodiment of the invention according to item J, said driveunit placed outside the blood stream comprises a stator, and the part ofthe valve placed inside the blood stream comprises a rotor, wherein saidstator supplies wireless energy to said part of the valve placed insidethe blood stream, causing rotational movement of at least a part of saiddrive unit.

M. In one embodiment of the invention according to item L, the driveunit further comprises both said rotor adapted to be placed outside theblood stream, said rotor comprising a magnetic coupling for driving atleast a part of the valve placed inside the blood stream with rotationalenergy, the method further comprising the steps of:

-   -   placing said stator and rotor on the outside of said valve        including a magnetic coupling in the placement area, wherein        said rotor comprises said magnetic coupling, adapted to be        magnetically connecting to said valve placed inside the blood        stream,    -   supplying energy to said stator to rotate said rotor and thereby        rotating said valve, thereby    -   causing, through the magnetic coupling, rotating movement of        said valve.

N. In one embodiment of the invention according to any of items A-M, anopening is performed from the abdomen through the thoracic diaphragm forplacing the energy receiver or energy source in the abdomen.

O. In one embodiment of the invention according to any of items C, D andN, said opening is performed in the thoracic diaphragm at the placewhere the pericardium is attached to the thoracic diaphragm.

P. In one embodiment of the invention according to any of items A-O, thevalve or drive unit uses energy, direct or indirect, from an externalenergy source, supplying energy non-invasively, without any penetrationthrough the patient's skin to power the valve or drive unit.

Q. In one embodiment of the invention according to any of items A-H,said valve or drive unit is connected to an internal energy source via acable, the method of placement further comprising;

-   -   dissecting and placing a wire connected to the valve or drive        unit into the right atrium of the heart and further up in the        venous blood vessel system,    -   exiting the system in or closer to the subcutaneous area, such        as in the vena subclavia, vena jugularis or vena brachialis        placing an internal energy source in the subcutaneous area or        close thereto or in the thorax or abdomen,    -   supplying from an external energy source energy non-invasively,        without any penetration through the patient's skin to power the        internal energy source for indirect or direct power the valve or        drive unit.

R. In one embodiment of the invention according to any of items A-H, themethod of placement further comprises;

-   -   placing an electrode in the right atrium or ventricle of the        heart    -   placing the wire to the electrode via the right atrium of the        heart and further up in the venous blood vessel system,    -   exiting the blood vessel system in or closer to the subcutaneous        area, such as in the vena subclavia, vena jugularis or vena        brachialis,    -   placing an internal control unit in the subcutaneous area or        close thereto or in the thorax or abdomen, the method further        comprising at least one of the following steps;    -   receiving sensor input relating to electrical pulses or muscle        contractions of the heart or    -   transmitting energy pulses from said electrode for controlling        heart contractions,    -   coordinating the valve or drive unit.

In various embodiments, the artificial valve of the invention alsoexhibits the following features:

A. The artificial valve is adapted to pass through a laparoscopic trocarin the patient's body.

B. The artificial valve is adapted to pass through an opening in thediaphragm muscle from the abdominal side.

C. The artificial valve is adapted to be inserted into the femoralartery and is further adapted to be released inside of the heart orblood vessel.

D. The artificial valve of item A, also comprising a drive unit for atleast partly powering the valve movements, adapted to be placed insidethe blood stream including a blood vessel or heart.

E. The artificial valve of item A, comprising a drive unit for at leastpartly powering the valve movements, adapted to be placed outside theblood stream including a blood vessel or heart.

F. The artificial valve of items D or E, wherein said drive unit isadapted to supply wireless or magnetic energy, said valve being adaptedto receive said wireless or magnetic energy to cause movements of saidvalve.

G. The artificial valve of item D or E, wherein said drive unitcomprises a stator, adapted to be placed outside the blood stream, theblood vessel or heart, and further comprising a rotor adapted to beplaced inside the blood stream, wherein said stator is adapted to supplywireless or magnetic energy to the rotor placed inside the blood stream,causing movements of at least a part of said valve placed inside theblood stream.

H. The artificial valve of item D or E, wherein said drive unitcomprises a stator and a rotor, adapted to be placed outside the bloodstream, the blood vessel or heart, said rotor comprising a magneticcoupling for driving at least a part of the valve placed inside theblood stream with kinetic energy.

I. The artificial valve of item A, wherein an energy receiver or energysource is adapted to be placed in the abdomen.

J. The artificial valve of item D or E, comprising an electric wireadapted to connect said valve or drive unit to an internal energysource, said wire adapted to pass into the right atrium of the heart andfurther up in the venous blood vessel system, exiting the blood vesselsystem in or closer to the subcutaneous area, wherein said internalenergy source is adapted to be connected to said wire via thesubcutaneous area.

K. The artificial valve of item A, comprising;

-   -   an internal control unit,    -   a sensor sensing physiological electrical pulses or muscle        contractions of the heart,    -   wherein said control unit controls said valve according to the        sensed information.

L. The artificial valve of item J:

in which said internal energy source comprises an internal control unitadapted to transmit energy pulses to said electrode for achieving andcontrolling heart contractions, wherein said control unit is adapted tocoordinate the valve or drive unit.

The invention is not limited to the examples of embodiments describedabove and shown in the drawings, but may be freely varied within thescope of the appended claims.

The invention claimed is:
 1. An artificial valve for implantation into amammal blood vessel in a mammal body, the artificial valve comprising acasing and a closing mechanism, with at least part of said closingmechanism being a first moving part adapted to make movements relativeto said casing and perpendicular to an extension of the blood vessel,and wherein said casing further comprises a protruding guide whichextends from the casing and which is adapted to be placed partiallyinside of a lumen of the blood vessel, for guiding the movements of thefirst moving part, wherein said movements being movements to assume anopen and a closed position for opening and closing, respectively, bloodflow through said blood vessel, as well as to assume positions inbetween said open and said closed positions, wherein the first movingpart is adapted to have at least one portion of said moving partassuming a position at least partially inside of said lumen of saidblood vessel, and a position at least partially external to said bloodvessel, wherein an end of said at least one portion positioned insidesaid lumen of said blood vessel extends at least half the length of saidlumen's inner width and has a convex shape corresponding to, and beingable to tightly fit against, a distal inner wall of the blood vessel inorder to close or limit flow of blood through said blood vessel, andwherein said casing comprises an outer wall having a concave shapematching said convex shape of said at least one portion of said firstmovable part, wherein said outer wall is adapted to be arranged on aradially outer side of said lumen's distal inner wall.
 2. The valve ofclaim 1, in which said closing mechanism comprises a coil which isadapted to be energized so as to cause said movements of the firstmoving part.
 3. The valve of claim 1, in which the first moving part isadapted to, when the valve is arranged in or adjacent to an opening insaid blood vessel, move in the opening in the blood vessel to limit orclose the blood flow through said vessel, with at least an outer portionof said first moving part assuming a position external to said bloodvessel in a non-closed position.
 4. The valve of claim 1, in which saidouter wall of the casing is concavely curved to coincide with an outershape of the blood vessel, said outer wall also comprising an openingfor the first moving part, through which opening it moves in its saidmovements, with a tolerance between a dimension of the opening and adimension of the first moving part being such that the movements areenabled, but also such that leakage of blood between the first movingpart and the opening is eliminated.
 5. The valve of claim 1, comprisinga detachable part for attachment to one or more protruding outer partsor to the casing, so that the valve completely surrounds the bloodvessel by means of the one or more protruding outer part and saiddetachable part and/or by means of an outer wall of the valve.
 6. Thevalve of claim 1, adapted to pass through a laparoscopic trocar in apatient's body, and further adapted to be inserted into a femoral arteryand further adapted to be released inside a heart or the blood vessel.7. The valve of claim 1, in which the closing mechanism comprises atleast one of: (a) a first coil, which is adapted to be energized so asto cause said movements relative to said casing; (b) a second coil,which is adapted to be energized stepwise with two or more energy pulsesso as to cause said movements relative to said casing; (c) a pluralityof coils, which are adapted to be energized stepwise so as to cause saidmovements relative to said casing.
 8. The valve of claim 1, in which thefirst moving part comprises an elongated flat plate, which is adaptedto, when the valve is arranged in or adjacent to an opening in saidblood vessel, move in a direction perpendicular to said blood vessel tolimit or close the blood flow through said vessel, with at least anouter portion of said first moving part assuming a position external tosaid blood vessel in a non-closed position.
 9. The valve of claim 1, inwhich the closing mechanism is housed in the casing with the firstmoving part being adapted to protrude from a housing during its movementtowards said closed position.
 10. The valve of claim 1, wherein saidprotruding guide comprises longitudinal grooves for guiding said firstmoving part along the movements relative to said casing of the firstmoving part.